IKON 40 手动轮椅
K号: K190550 · 2019-07-01
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决定日期2019-07-01
产品代码IOR
咨询委员会PM
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器械摘要
IKON 40 Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Broda Seating (Broda Lp). It received FDA 510(k) clearance on 2019-07-01 under 510(k) number K190550. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IKON 40 Manual Wheelchair?
IKON 40 Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2019-07-01. The listed applicant is Broda Seating (Broda Lp). The 510(k) number is K190550.
When did IKON 40 Manual Wheelchair receive FDA 510(k) clearance?
IKON 40 Manual Wheelchair received FDA 510(k) clearance on 2019-07-01, under 510(k) number K190550.
Who is the listed applicant for IKON 40 Manual Wheelchair?
The FDA 510(k) record lists Broda Seating (Broda Lp) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IKON 40 Manual Wheelchair?
The FDA product code for IKON 40 Manual Wheelchair is IOR.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：IOR）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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